Bioprocess Specialist - CONTRACT

GeneFab; Alameda (CA); On-site; USD 55,104 - 68,880; Full time

Job summary

GeneFab's Bioprocess Specialist II plays a critical role in cell and gene therapy manufacturing, performing upstream and downstream steps in a GMP cleanroom. You will troubleshoot, manage deviations, train staff, and contribute to 5S and other improvement initiatives to ensure on-time delivery and right-first-time execution of batches.

You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.

Qualifications

• Minimum high school diploma or equivalent; Associate or higher in Biology/Life Science/Engineering preferred.
• 3–4 years in biotech/pharma manufacturing, preferably in a cleanroom.
• Familiarity with cGMP and Good Documentation Practices.
• Proficient in aseptic techniques and pipetting.

Responsibilities

• Execute upstream and downstream manufacturing in a GMP cleanroom.
• Complete batch records and documentation per GDP.
• Lead production activities and ensure cGMP adherence.
• Train staff in processing methods and aseptic technique.
• Support deviation management and CAPA closures.
• Collaborate with Operations, MSAT, Quality, and Facilities.

Skills

Aseptic techniques

GMP compliance

Documentation practices

Teamwork and communication

Education

Associate or higher degree in Biology, Life Science, or Engineering

High School diploma

Job description

The Bioprocess Specialist II plays a critical role in the cell and gene therapy manufacturing processes at GeneFab. This position involves executing both upstream and downstream processes in a GMP-compliant cleanroom environment, with responsibility for troubleshooting, deviation management, training, and contributing to 5S and other improvement initiatives with the goal of ensuring on time delivery and right first-time execution of Manufacturing batches. You will collaborate with Operations, MSAT, Quality, and Facilities teams to ensure consistent production outcomes.

Responsibilities:

• Technicalproficiencyin aseptic techniques working with manufacturing equipment/instruments in open and closed systems
• Organize, coordinate, and lead production activities and ensure execution of processes in production while strictly adhering to cGMP standards
• Accurately complete batch records, forms, and documentation in line with Good Documentation Practices (GDP).
• Work as part of a team to support the execution of daily GMP manufacturing activities.
• Train staff in processing methods, aseptictechnique, and cGMP clean room operations.
• Review batch production records for completeness, accuracy, and to ensurecGMPsand Good Documentation Practices.
• Initiate and support the closure of Deviation Reports and CAPAs
• Other duties as assigned by management.

Qualifications:

• Minimum High School diploma or equivalent experience isrequired. Associates or higherdegreein Biology, Life Science, or Engineeringispreferred.
• 3-4 minimum years of experience in biotech or pharmaceutical manufacturing, preferably in a cleanroom environment.
• Familiarity with cGMP standards and basic understanding of Good Documentation Practices.
• Proficiencyworking in cGMP cleanrooms and aseptic techniques
• Advanced understanding of pipetting and micro pipetting.
• Demonstrated ability toidentify, challenge, and implement potential improvements to work procedures.
• Ability to work flexible hours, including nights and weekends, as schedules may shift in this start-up environment.
• Ability to stand for extended periods and lift upto 20 pounds.
• Strong communicationand teamwork skills, with a willingness to learn.

$40 - $50 an hour

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.